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Management of Peyronie's Disease With Adipose Tissue Stem Cell

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ClinicalTrials.gov Identifier: NCT02414308
Recruitment Status : Unknown
Verified April 2015 by Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction.
Recruitment status was:  Recruiting
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance

Condition or disease Intervention/treatment
Erectile Dysfunction Peyronie' Disease Drug: Adipose tissue stem cell injection

Detailed Description:
Peyronie's disease associated with erectile dysfunction nan be treated by different methods We start to treat such patients with adipose tissue stem cell Harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to Peyronie's disease

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Adipose Tissue Stem Cell Injection Through Corpora Cavernosa and Intra Dorsal Penile Artery in Management of Erectile Dysfunction Associated With Peyronie's Disease
Study Start Date : June 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Adipose tissue stem cell injection
The stem cell will be harvested by liposuction and injection will be at corpora cavernosa and dorsal penile artery
Drug: Adipose tissue stem cell injection
Stem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery


Outcome Measures

Primary Outcome Measures :
  1. sexual function questionnaire [ Time Frame: 2-3 months ]
    Clinical history of patients before and after treatment Penile duplex study


Secondary Outcome Measures :
  1. Penile plaque assessment [ Time Frame: 2-3 months ]
    Clinical examination Patient history Penile duplex


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • erectile dysfunction associated with Peyroni's diseas

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414308


Contacts
Contact: Khaled A Gadalla, MD, ABS 20222725025 Khaledgadalla@gmail.com

Locations
Egypt
Man clinic Recruiting
Cairo, Egypt, 11366
Contact: Khaled A Gadalla, MD, ABS    20222725025    Khaledgadalla@gmail.com   
Principal Investigator: Khaled A Gadalla, MD, ABS         
Man clinic for andrology and male infertility Recruiting
Cairo, Egypt, 33611
Contact: Khaled A Gadalla, MD, ABS    20222725025    Khaledgadalla@gmail.com   
Sponsors and Collaborators
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Investigators
Principal Investigator: Khaled A Gadalla, MD, ABS Man clinic
More Information

Responsible Party: Khaled Abdulmoneim Gadalla, Dr, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
ClinicalTrials.gov Identifier: NCT02414308     History of Changes
Other Study ID Numbers: 003
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction:
Erectile dysfunction, Peyronie's disease, stem cell

Additional relevant MeSH terms:
Erectile Dysfunction
Penile Induration
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Penile Diseases
Connective Tissue Diseases